MMJ International Holdings Shipping THC and CBD to US For Clinical Trials
ST. PETERSBURG, Fla., Aug. 20, 2019 /PRNewswire-PRWeb/ -- MMJ International Holdings, the premier medical cannabis research company, announced that it will begin preparations to ship THC and CBD from Canada. MMJ International Holdings is developing an oral drug product from natural whole plant extract derivatives from the marijuana plant containing THC and CBD. MMJ will be utilizing its new product for a FDA approved treatment of multiple sclerosis (MS) and Huntington's disease (HD). It is asking the US Drug Enforcement Agency's approval to ship the compounds for its clinical trials.
"As MMJ International Holdings continues to advance to its clinical trials, gel cap manufactures will be supporting MMJ with the FDA, DEA required development API and specialized liquid encapsulation solutions," said Elio Mariani, PhD, EVP of research & development. "Patients will benefit from cGMP-quality therapies in an accessible and efficient format."
Most recently the FDA awarded MMJ International Holdings "Orphan Drug Designation" for its THC and CBD proprietary drug formulation which will be used for the treatment of Huntington's Disease. The drugs, MMJ-001 and MMJ-002, are two of MMJ's lead drugs that the company is confident will bring much needed relief to patients suffering from the debilitating effects of Multiple Sclerosis and Huntington's Disease.
"We firmly believe that our MMJ natural whole plant derived molecules with a unique combination of pharmacological properties will be FDA approved as a safe and effective prescription drug that can be of great benefit in treating patients with MS and HD diseases," said Duane Boise, CEO of MMJ International Holdings. "We are pleased with the DEA 's cooperation and support to facilitate our company mission to service the unmet needs of patients suffering from these chronic diseases."
Tim Moynahan the company chairman stated that, "Patients in the MMJ International holdings scheduled clinical trials will receive gelatin capsules containing THC and CBD daily." MMJ International Holdings has several academic institutions preparing to study cannabis in Multiple Sclerosis and Huntington's disease. MMJ clinical trials will provide the necessary data to prove that cannabis can treat essential tremors a neurological disorder that causes involuntary shaking. "Ultimately, there's so much interest in THC and CBD as a treatment modality, so MMJ will be providing the clinical research data necessary to prove patient dosing safety and efficacy he further stated."
On March 28, the FDA issued warning letters to three CBD product sellers. The FDA alleged false, unfounded, unsubstantiated and egregious health claims about their products' ability to limit, treat or cure without sufficient evidence or FDA approval. The FDA further threatened product seizures, injunctions and sales proceeds seizure. The FDA warning letters stated that CBD:
1. Is not generally recognized as safe and effective for these uses and, therefore, rendered "new drugs" under Section 201(p) of the FDA Act that are barred from being introduced into interstate commerce without prior FDA approval (which is solely provided on the basis of scientific data and information demonstrating that drug is safe and effective);
2. CBD that is misbranded under Section 502(f)(1) of the FDA Act for failing to bear adequate "intended use(s) directions" defined as "directions under which a layperson can use a drug safely and for the {intended} purposes" or as "prescription drugs" which "can only be used safely at the direction, and under the supervision, of a licensed practitioner"; and
3. CBD that is intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without a licensed practitioner's supervision" and for which it is "impossible to write adequate directions for."
Therefore, MMJ International Holdings continues its process of scientific drug development and discovery by FDA protocol development processes, intellectual property portfolio and DEA regulatory manufacturing guidelines.
SOURCE MMJ International Holdings
